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Periurethral Pro-ACTTM Balloons vs Retrourethral AdvanceTM Male Sling for Post-prostatectomy Incontinence (BALLANCE)

This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01500603
First received: December 23, 2011
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

Background: Periurethral Pro-ACT balloons and retrourethral Advance male sling have been presented as efficient treatments for management of stress urinary incontinence (SUI) following radical prostatectomy (RP), but no comparative study of these two techniques has been published. The investigators aims were to compare the efficacy of the two devices and provide data about their cost effectiveness.

Hypothesis: The study is based on the superiority hypothesis that Advance male slings is more efficacious than Pro-ACT balloons at one year follow-up.

Primary objective: The primary objective of this study is to compare the efficacy of the Advance retrourethral male sling and periurethral Pro-ACT balloons management of SUI after RP at one year follow-up.

Secondary objectives:

  • Comprehensive comparative medical evaluation of the two devices in terms of efficacy
  • Complete evaluation of the side effects of the two techniques
  • Evaluation of the quality of life
  • Evaluation of patient satisfaction
  • Cost-effectiveness study of the device (total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system) Population: Patients with history of RP without cancer recurrence, presenting pure SUI on urodynamics (without detrusor overactivity), of mild to moderate degree (24hour pad-test < 300g).

Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers), comparative trial of the two devices (with a superiority hypothesis). The total number of subjects required is 240 and inclusion period is 12 months. Follow-up consists in 4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report of any secondary effect). Statistical evaluation is carried out at the end of the follow-up, in intent to treat.

Medical evaluation:

Main criterion:failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI.

Secondary outcome criteria

  • pad usage per day
  • quantitative reduction of the 24hr-pad test
  • complications (infection, erosion, hematoma, acute urinary retention)
  • number of re-interventions or re-admissions during follow-up
  • quality of life measured by the ICIQ-SF questionnaire
  • patient satisfaction by the PGI-I questionnaire

Economic evaluation:

  • Study of the total cost over one year in each case
  • Adjustment of cost of each device to quality of life (QALY evaluation)
  • Cost effectiveness study
  • Proposals will be made to state at which level the two devices should be covered by the healthcare system.

Condition Intervention
Stress Urinary Incontinence
 Device: Advance Male sling device
Device: Pro-ACT balloon device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Multicentric, Comparative Trial of Two Devices in Surgical Treatment of Post-radical Prostatectomy Stress Urinary Incontinence: Periurethral Pro-ACTTM Balloons and AdvanceTM Retrourethral Male Sling

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI management in the year after operation [ Time Frame: 12 months after surgical treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complications [ Time Frame: 1, 3 6 and 12 months after surgical treatment ] [ Designated as safety issue: Yes ]
    • pad usage per day
    • quantitative reduction of the 24hr-pad test
    • complications (infection, erosion, hematoma, acute urinary retention)
    • number of re-interventions or re-admissions during follow-up
    • quality of life measured by the ICIQ-SF questionnaire
    • patient satisfaction by the PGI-I questionnaire

  • Cost-effectiveness study of the device [ Time Frame: 12 months after surgical treatment ] [ Designated as safety issue: No ]
    [Total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system]


Estimated Enrollment: 240
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Patients will receive Advance retrourethral male sling implantation under general or loco-regional anaesthesia, by perineal approach. The sling is placed via transobturator route
 Device: Advance Male sling device
Patients will receive Advance retrourethral male sling (polypropylene mesh) implantation under general or loco-regional anaesthesia, by perineal approach. The sling is placed via transobturator route.
Active Comparator: Active comparator
Patients will receive Pro-ACT balloons implantation under general or loco-regional anaesthesia, by perineal approach. The balloons are placed under X-ray control laterally to the urethra, under the bladder neck. The extremity of the device (titanium port), linked to the balloon, is located subcutaneously in the scrotum. During post-operative visits, readjustments of the volume of the balloons will be made under local anaesthesia. The volume will be increased or decreased according to the patients symptoms.
 Device: Pro-ACT balloon device
Patients will receive Pro-ACT balloons implantation under general or loco-regional anaesthesia, by perineal approach. The balloons are placed under X-ray control laterally to the urethra, under the bladder neck. The extremity of the device (titanium port), linked to the balloon, is located subcutaneously in the scrotum. During post-operative visits, readjustments of the volume of the balloons will be made under local anaesthesia. The volume will be increased or decreased according to the patients symptoms.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Patient presenting mild to moderate stress urinary incontinence (20g < 72 hours pad-test < 300g) following radical prostatectomy more than 1 year ago.
  • Patient capable of roaming, independent and capable of using toilet without any trouble.
  • Patients able to answer to questionnaire and communicate in French
  • Informed consent
  • Patients with social security

Exclusion Criteria:

  • Uncontrolled prostatic adenocarcinoma or PSA > 1 ng/ml
  • Maximum urinary flow rate < 15 ml/sec
  • Postvoid residual volume > 150 ml
  • Urinated volume in 24h > 3000 ml
  • Uninhibited detrusor contractions associated with leakage during the preoperative urodynamic assessment (realized under anticholinergic if the patient is usually under this medication)
  • Severe incontinence (Pad test > 300g/24h)
  • History of artificial urinary sphincter
  • Known neurologic bladder dysfunction
  • History of neurological disease which can interfere with the urinary symptoms
  • Presence of a urethral stenosis or of an anastomotic stricture during the preoperative endoscopy.
  • Previous treatment with pelvic radiation therapy in 6 months before inclusion
  • Uncontrolled urinary tract infection
  • Patients affected by an infiltrative bladder tumour
  • Patients with bladder stones
  • Severe constitutional hemorrhagic disease or haemophilia
  • Deep depression of immune system
  • Severe renal impairment or obstructive pathology of the upper urinary tract with severe renal impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500603

Contacts
Contact: François Haab, MD, PhD + 33 (0)1 56 01 64 95 francois.haab@tnn.aphp.fr

Locations
France
Service d'urologie, Hôpital Tenon Recruiting
Paris, France, 75020
Contact: François Haab, MD, PhD     + 33 (0)1 56 01 64 95     francois.haab@tnn.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: François Haab Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01500603     History of Changes
Other Study ID Numbers: P100143
Study First Received: December 23, 2011
Last Updated: November 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
post-radical prostatectomy
stress urinary incontinence
periurethral Pro-ACT balloons
Advance retrourethral male sling

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013